HTI Halozyme Therapeutics

- Use of rHuPH20 Increases the Bioavailability of Subcutaneously Injected Biologic Therapeutic Agent - SAN DIEGO, Jan. 22 /PRNewswire-FirstCall/ -- Halozyme Therapeutics, Inc. (AMEX:HTI), a biopharmaceutical company developing and commercializing recombinant human enzymes, today announced the results of a clinical trial of Enhanze(TM) Technology intended to measure the improved absorption and bioavailability of a representative commercially-available large protein molecule therapeutic (LPMT). Enhanze Technology is Halozyme's enzyme-based drug delivery platform based on recombinant human PH20 hyaluronidase (rHuPH20). This clinical trial compared the pharmacokinetics (PK), safety, and tolerability of an LPMT agent subcutaneously injected first without Enhanze Technology (rHuPH20) and then with rHuPH20 in 15 patients. The open-label, dose escalation, within-patient controlled study used escalating dose cohorts of rHuPH20 (ranging from 1,600 U to 12,800 U) and substituted a standard subcutaneous (SC) injection of the LPMT with one SC injection of the LPMT agent combined with Enhanze Technology (rHuPH20). The study compared the bioavailability and other PK parameters, along with safety and tolerability, of the two SC injections, one with and one without Enhanze Technology (rHuPH20). The data from this clinical trial support the study hypothesis that rHuPH20 increases the relative bioavailability of the LPMT: * For the primary endpoint of area under the curve (AUC) for plasma concentration of the LPMT, the AUC over the 14 days following injection was higher when the LPMT was administered with rHuPH20 compared to without rHuPH20 for 100% (15/15) of the patients in the study. The addition of rHuPH20 increased the AUC above baseline (average trough level) of the LPMT for all cohorts combined by an average of 58%. * The mean relative AUC above baseline for LPMT with rHuPH20 compared to LPMT without rHuPH20 was 136% for 1,600 U rHuPH20 (N=3), 178% for 3,200 U rHuPH20 (N=3), 168% for 6,400 U rHuPH20 (N=3), and 150% for 12,800 U rHuPH20 (N=6). The study was not powered to statistically distinguish a dose-dependent effect for rHuPH20 dose cohorts. * The mean (for all cohorts combined) maximum concentration (Cmax) of LPMT was increased by 26% when LPMT was co-administered with rHuPH20, compared to LPMT without rHuPH20, and an increase in Cmax was observed consistently across all rHuPH20 dose cohorts. * The overall mean time to maximum plasma concentration (Tmax) of LPMT was not meaningfully altered by co-administration with rHuPH20. * Injection of rHuPH20 with the LPMT was well tolerated at all dose levels, without dose-limiting toxicity, premature withdrawal, or serious adverse events. * Of the five total adverse events reported in this study, two were assessed as having no association with either study drug (basal cell carcinoma and urinary tract infection). The remaining three events consisted of injection site erythema (redness) that occurred on the day of the injection of the combination of LPMT with rHuPH20. Each event was mild in severity and assessed as probably related to rHuPH20, and resolved within one or two days. * Additional safety outcome parameters included assessment of injection site pain, erythema, and edema. Patient self-assessment of pain on a 0 to 100 mm scale averaged 27 mm on the days of injection, with or without rHuPH20, and then decreased on subsequent days. Investigator reporting of erythema mirrored that for adverse events, as described above. There was no injection site edema reported. As a spreading agent, hyaluronidase has traditionally been used to accelerate the delivery of drugs and fluids, including local anesthetics, other co-injected drugs, and contrast agents, and for subcutaneous fluid replacement. Although a large body of clinical experience supports the benefits and safety of using hyaluronidase as an adjuvant to increase the absorption and dispersion of co-injected small molecule drugs, to Halozyme's knowledge clinical studies have not previously been performed to support the benefits and safety of recombinant human hyaluronidase use with large molecule agents, such as monoclonal antibodies and other large molecule biologics. rHuPH20 is the first and only FDA-approved hyaluronidase from recombinant human source. "The findings from this first clinical trial of Enhanze Technology provide proof of concept that rHuPH20 may also have clinical application for large molecule therapeutics," said Richard C. Yocum, MD, Vice President of Clinical Development and Medical Affairs at Halozyme. "Additional studies with larger patient sample sizes are warranted to further characterize the rHuPH20 effect, especially with regard to optimal dose, and to investigate the role that rHuPH20 may play in addressing unmet needs in the administration of large molecule agents, thereby opening up new areas of therapeutic indications." About Halozyme Therapeutics, Inc. Halozyme is a biopharmaceutical company developing and commercializing recombinant human enzymes for the drug delivery, palliative care, oncology, and infertility markets. The company's portfolio of products is based on intellectual property covering the family of human enzymes known as hyaluronidases. The company's Enhanze(TM) Technology is a novel drug delivery platform designed to increase the absorption and dispersion of biologics. Its first partnership is with Roche to apply Enhanze Technology to Roche's biological therapeutic compounds for 13 targets. In addition, the company has received FDA approval for two products: Cumulase(R) and Hylenex, for use as an adjuvant to increase the absorption and dispersion of other injected drugs and fluids. The Company also has a number of different enzymes in its portfolio that are targeting significant areas of unmet need. Safe Harbor Statement In addition to historical information, the statements set forth above include forward-looking statements (including, without limitation, statements concerning clinical trial results and the applicability of rHuPH20 to large protein molecule therapeutics) that involve risk and uncertainties that could cause actual results to differ materially from those in the forward-looking statements. The forward-looking statements are also identified through use of the words "believe," "enable," "may," "will," "could," "intends," "estimate," "anticipate," "plan," "predict," "probable," "potential," "possible," "should," "continue," and other words of similar meaning. Actual results could differ materially from the expectations contained in forward-looking statements as a result of several factors, including regulatory approval requirements and competitive conditions. These and other factors that may result in differences are discussed in greater detail in the company's reports on Forms 10-KSB, 10-Q, and other filings with the Securities and Exchange Commission. Halozyme Contact Investor Relations Contact David A. Ramsay Don Markley Chief Financial Officer Lippert/Heilshorn & Associates (858) 794-8881 (310) 691-7100 Media Contacts Megan Swanland Riggs / Joleen Schultz Mentus (858) 455-5500, x230/x215 DATASOURCE: Halozyme Therapeutics, Inc. CONTACT: David A. Ramsay, Chief Financial Officer of Halozyme, +1-858-794-8881, ; or Investor Relations, Don Markley of Lippert/Heilshorn & Associates, +1-310-691-7100, , for Halozyme; or Media, Megan Swanland Riggs, ext. 230, , or Joleen Schultz, ext. 215, , both of Mentus, +1-858-455-5500, for Halozyme

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